26 april 2013

Amendments for tobacco harm reduction by allowing snus and e-cigarettes

Electronic cigarettes and snus can help reduce the number of smoking related deaths in Europe

I have now tabled 19 amendments to the Tobacco Products Directive in the European Parliament Committee for the Internal Market and Consumer Protection IMCO.

The amendments are in favour of allowing snus (Swedish oral tobacco) and electronic cigarettes, as part of a harm reduction policy for tobacco products. My aim is to give current smokers the choice of giving up smoking in favour of the considerably less dangerous alternatives snus or e-cigarettes.

The ban on characterising flavours should only apply to tobacco products for smoking (Am 2 & 3). Flavours are integral to smokeless tobacco products and used in 70% of products, but only in 5% of cigarettes. Smokeless tobacco products are a much lower risk alternative to cigarettes and it is important to ensure smokeless tobacco products are not disadvantaged relative to cigarettes, and that smokers are incentivised to switch. Given the low rates of smoking and smoking related disease in Sweden, and that this is largely attributable to oral tobacco only available in Sweden, it would be wrong for the EU to legislate for changes that apply to oral tobacco if the government of Sweden is opposed, especially in the absence of any evidence that this will have a beneficial effect rather than undermine the pronounced health benefits arising from the oral tobacco experience in Sweden.

Let Member States decide for themselves if they want to continue to ban snus or not (Am 5). If a member state believes it is culturally accepted and makes a valuable contribution to public health, then surely it is a matter for the member state – in other words, each member state should have the right, but not the obligation to do what Sweden has done. Even if there is no intent to lift a ban now, the flexibility to do it in future is valuable. Different treatment may be justified in different member states because of different cultures and differing estimates of public health impact in different cultural contexts.

Set maximum limits for toxic or carcinogenic substances present in smokeless tobacco products (Am 6, 7 & 18). This replaces a ban on oral tobacco with a product quality standard for all smokeless tobacco. Rather than banning the least hazardous smokeless tobacco products (i.e.: snus), this will have the effect of removing the most hazardous from the market, and it is therefore consistent with the health objectives of the internal market. This section reproduces the regulatory recommendations of the WHO Study Group on Tobacco Product Regulation – Report on the Scientific Basis of Tobacco Product Regulation, WHO Technical Report Series, no. 955. (2010)

Update the health warning on snus (Am 4) to read:

This tobacco product can damage your health and is addictive, but presents substantially lower risks to your health than smoking

It is more important to provide information about relative risk than make unquantified statements about harm. The proposed message gives a clear evidence-based signal to tobacco users.

Taken together, my amendment 1-7 and 18 would allow (but not force) member states to lift the ban on snus, and provide a common regulatory framework if they do.

Electronic cigarettes are currently not regulated by any specific legislation, but only by the general product safety and consumer protection legislation (of which there actually is quite a lot, see below). The Commission’s proposal is to regulate e-cigarettes as medicines (making them subject to a time-consuming and expensive authorisation procedure), and to lower the maximum nicotine yield to a level that would be too low to make them a viable alternative for many smokers who might otherwise consider giving up smoking in favour of e-cigarettes.

My amendments on electronic cigarettes (8 – 17 and 19) aim to do the following:

Only products marketed as medicines should be placed under the medicines directive 2001/83/EC (Am 8 – 11, 13 – 15). The distinction between whether medicines regulation or consumer regulation is applied should rest on whether a therapeutic health claim is made, not on an arbitrary threshold on nicotine yields. This limits the application of medicines regulation to those vendors making health claims consistent with the medicines regulation definition, and ensures that the Tobacco Products Directive applies to all other nicotine-containing products. It rules out member states classifying nicotine-containing products as medicines under Article 1.2(b) of the medicine directive 2001/83/EC – the ‘functional’ definition based on changes to physiology – an approach that has been repeatedly struck down in courts in Europe and clearly does not apply to the dominant nicotine product, cigarettes.

Evaluate existing legislation (Am 12 & 19) and how it is applied in the member states, to provide data for a Commission review of the regulatory framwork for electronic cigarettes (Am 16). Nicotine containing products are potentially a huge market and vital for public health as an alternative to cigarettes. It is important that regulation is designed with care and is legally robust – not to be excessively burdensome or too general to capture any specific risks arising from the products.

All the amendments that I have tabled were originally drafted by anti-smoking activist Clive Bates, who published his suggestions in a blog post titled Amending the Tobacco Products Directive – how to fix the harm reduction agenda. That blog post contains further explanations and justifications for the amendments. In order to keep the number of amendments down, I have only tabled the most important ones for snus and e-cigarettes.

Tobacco smoking causes 700.000 premature deaths per year in the European Union. If we could bring smoking prevalence in the EU down from its current level of 28% to the Swedish level of 13%, we would save 350.000 lives per year.

The amendments I have tabled aim to make this harm reduction agenda a reality in Europe.

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Declaration of interest: I am a snus user, which has allowed me to cut down my smoking drastically, even though I have not stopped completely yet. My wife used to smoke, but gave it up completely several years ago by switching to eucalyptus flavoured snus.

[…] I have now tabled 19 amendments to the Tobacco Products Directive in the European Parliament Committee for the Internal Market and Consumer Protection IMCO. The amendments are in favour of allowing… […]